OneQ-SL s-Clean Implant System by DENTIS CO., LTD.

The OneQ-SL s-Clean Implant System is in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Device Description

The OneO-SL s-Clean Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body, bone level and submerged type that are similar to other commercial available products based on the intended use, technology used, the claims, the material composition employed and performance characteristics. This implant system is supplied by gamma sterilized that is same with almost all dental implant. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the Dentis dental implant system (K073486) of DENTIS Co., Ltd., and Dentis dental implant system(K150344) of DENTIS Co., Ltd. The difference between the subject and the predicate device are slightly different shape and surface treatment. This subject device is compatible with the abutments of K073486, K082843, K111364 and K150344.

AI/ML Overview

This document describes the OneQ-SL s-Clean Implant System, an endosseous dental implant. The purpose of the submission is to demonstrate its substantial equivalence to predicate devices, thus no clinical testing was performed.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission demonstrating substantial equivalence rather than a clinical trial with specific performance metrics defined by acceptance criteria for a novel device, the concept of "acceptance criteria" and "reported device performance" are framed differently. The acceptance criteria here are adherence to relevant standards and demonstration of equivalence to legally marketed predicate devices. The "reported device performance" is the successful completion of non-clinical tests meeting these standards and showing similarity to predicates.

Acceptance Criteria Category	Specific Criteria / Standards Adhered To	Reported Device Performance
Biocompatibility	ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11	Tests performed in accordance with stated ISO standards; results met standards.
Sterilization	ISO 11137-1	Gamma Sterilization Validation Test performed; results met standards.
Shelf Life	ISO 11607-1, -2, ASTM F1980-07	Shelf life Validation Test performed; results met standards.
Fatigue Testing	"Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutments"	Submitted fatigue test report of the predicate device (K150344) used as proof for the OneQ-SL s-Clean Implant System, indicating it met the requirements through worst-case scenario testing.
Substantial Equivalence	Similarity in intended use, material, connection structure, packaging, function, abutment use, performance, design, technology, dimensions to predicates. Non-clinical tests demonstrate equivalence.	The device is similar to predicates in numerous aspects (material, design, dimensions, indications for use, surface treatment, sterilization, product code). Differences (e.g., specific fixture diameters, thread shape) do not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The "test set" here refers to the non-clinical tests performed on the device itself and its components. These tests typically involve a specific number of samples required by the particular testing standard (e.g., a certain number of parts for fatigue testing). The document does not specify these exact numbers for each test but indicates tests were "performed to evaluate its substantial equivalence."
Data Provenance: The document does not explicitly state the country of origin for the non-clinical test data. However, the manufacturer is Dentis Co., Ltd. located in Daegu, South Korea. It's highly probable the non-clinical testing was conducted there or arranged by them, adhering to international standards. The tests were prospective in the sense that they were performed specifically to support this regulatory submission, but they are non-clinical tests on the device materials and design, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a 510(k) submission for a physical medical device (dental implant), not an AI algorithm or diagnostic tool that requires expert human interpretation to establish ground truth for a test set. The "ground truth" for this device's performance is established by its adherence to engineering and material strength standards and biocompatibility tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method (common in clinical trials or AI studies with expert review) is not relevant for the non-clinical, bench-top integrity and performance tests described for this dental implant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic or treatment planning tool. It is a dental implant (physical device). No MRMC studies were conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by the established international and ASTM standards (e.g., ISO 10993 series for biocompatibility, ISO 11137-1 for sterilization, ISO 11607-1/-2 and ASTM F1980-07 for shelf life, and the FDA's Class II special controls guidance for fatigue testing). The device's performance is compared against the pass/fail criteria specified within these standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As noted above, this involves no AI model or training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 8, 2016

Dentis Co., Ltd. c/o Ms. April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K153639

Trade/Device Name: OneQ-SL s-Clean Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 3, 2016 Received: March 11, 2016

Dear Ms. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. April Lee

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153639

Device Name

OneQ-SL s-Clean Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

D Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for DENTIS. The logo consists of an orange abstract shape on the left and the word "DENTIS" in black, bold letters on the right. The abstract shape is a curved shape with a circle at the top, resembling a stylized flame or drop.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

510(K) Summary

Submitter

Dentis Co., Ltd. Sun Chul Shin 99, Seongseoseo-ro, Dalseo-gu Daegu. 42718 South Korea Phone: +82-53-583-2804 Fax: +82-53-583-2806

Official Correspondent

Withus Group Inc. April Lee 2531 Pepperdale Drive Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 909-274-9971 Fax: 909-460-8122

Device Information

Trade Name: OneQ-SL s-Clean Implant System Common Name: Endosseous Dental Implant Classification Name: Endosseous dental implant Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 4/7/2016

Description

The OneQ-SL s-Clean Implant system diameter and lengths are below:

The OneQ-SL s-Clean Fixtures Internal Hex-connected, Bone level, submerged fixture, Tapered & Straight body Implant Fixture Dimension:

Division	Platform Diameters(Fixture Diameters)	Body Diameters	Lengths
Regular	Ø3.7	Ø3.5
	Ø3.9	Ø3.6
	Ø4.2	Ø3.7	7, 8, 10, 12, 14 mm
	Ø4.7	Ø4.2
	Ø5.2	Ø4.7
Wide	Ø6.0	Ø4.8	7, 8, 10, 12 mm

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Image /page/4/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that resembles a stylized flame or a curved shape with a circular element at the top. The overall impression is that of a company logo or brand mark.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

	Ø7.0	Ø5.8
	Ø8.0	Ø6.8

The fixture and cover screw are made of CP Titanium Grade 4. The surface is treated by Sand -blasting (Large grit) and acid etching method (SLA). This system only contains the implant bodies with cover screw and are provided as set-packing. The purpose of this submission is to add new fixtures.

Indications for Use

The OneO-SL s-Clean Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

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Image /page/5/Picture/0 description: The image contains the word "DENTIS" in bold, sans-serif font. To the left of the word is an orange graphic. The graphic is a curved shape with a circle at the top.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

Predicate Devices & Comparison

The subject device is substantially equivalent to the following predicate devices:

K150344/K073486, Dentis Dental Implant System manufactured by Dentis Co., Ltd. ●
K142313, OneQ-SL Implant System manufactured by Dentis. Co., Ltd. .
K063216, Rescue Internal Dental Implant System by Megagen Co., Ltd. ●

Division	Subject Device	Predicate		Predicate	Predicate
Device Name	OneQ-SL s-CleanImplant System	Dentis Dental ImplantSystem	Dentis Dental ImplantSystem	OneQ-SL Implant System	Rescue Internal DentalImplant System
510(k) Number	N/A	K073486	K150344	K142313	K063216
Manufacturer	DENTIS CO., LTD.	DENTIS CO., LTD.	DENTIS CO., LTD.	DENTIS CO., LTD.	MEGAGEN Co., Ltd.
Material	CP Titanium Gr.4	CP Titanium Gr.4	CP Titanium Gr.4	CP Titanium Gr. 4	CP Titanium Gr. 4
Design(Fixture Type)	Image: Two implants- Internal Hex-connected- Submerged Fixture-Bone level- Tapered & straightbody- 3 sided cutting edgewith self-tapping	Image: Implant-Internal Hex-Connected-Submerged Fixture-Bone level, Taperedbody- 4 sided cutting edgewith self-tapping	Image: Implant-Internal Hex-Connected-Submerged Fixture-Bone level, Taperedbody- 4 sided cutting edgewith self-tapping	Image: Two implants- Internal Octa-connected- Non Submerged Fixture- Tapered & straight body- 3 sided cutting edge withself-tapping	Image: Implant-Internal Hex-connected-Submerged Fixture-Bone level, Straightbody-4 sided cutting ecgeand self-tapping
Fixture Diameter	Regular: Ø 3.7, Ø 3.9,Ø 4.2, Ø 4.7, Ø 5.2Wide: Ø 6.0, Ø 7.0, Ø 8.0	Ø 3.5, Ø 3.7, Ø 4.1, Ø4.3, Ø 4.8, Ø 5.1, Ø5.5, Ø 6.0, Ø 6.5, Ø7.0	Ø 3.7, Ø 4.1, Ø 4.3, Ø 4.8	Regular(4.8 Platform):Ø 3.7, Ø 4.2, Ø 4.7, Ø 5.2Wide(6.5 Platform): Ø 4.7,Ø 5.2, Ø 6.0, Ø 7.0	Ø 6.0, Ø 6.5, Ø 7.0, Ø 8.0
Fixture Length	Regular: 7, 8, 10 ,12, 14mmWide: 7, 8, 10 ,12 mm	7, 8, 9, 10, 12, 14 mm	7, 8, 10, 12, 14 mm	Regular: 7, 8, 10, 12, 14mmWide(Ø4.7, Ø5.2): 7, 8,10, 12, 14mm	7.0~12.5mm
				Wide( $\varnothing$ 6.0, $\varnothing$ 7.0): 7, 8, 10, 12mm
Indication for use	The OneQ-SL s-CleanImplant System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple unitrestorations including;cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework. Thissystem is dedicated forone and two stagesurgical procedures.This system isintended for delayedloading.	The Dentis DentalImplant System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorations including;cemented retained,screw retained, oroverdenturerestorations, andterminal orintermediate abutmentsupport for fixedbridgework. Thissystem is dedicatedfor one and two stagesurgical proceduresand not dedicated forimmediate loading.This system isintended for delayedloading.	The Dentis DentalImplant System is anendosseous dentalimplant is indicated forsurgical placement in theupper and lower jawarches, to provide a rootform means for single ormultiple-units prostheticappliance attachment torestore a patient'schewing function.Implants can be placedwith a conventional twostage surgical processwith an option fortransmucosal healing orthey can be placed in asingle stage surgicalprocess for immediateloading. Immediateloading is restricted tothe anterior mandiblebased on four splintedinterforminal placedimplants.	The OneQ-SL ImplantSystem is indicated for usein partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate abutmentsupport for fixedbridgework. This system isintended for delayedloading.	The Rescue InternalImplant System isintended to be surgicallyplaced in the maxillaryor mandibular molarareas for the purposeproviding prostheticsupport for dentalrestorations(Crown,bridges andoverdentures) inpartially or fullyedentulous individuals.These implants areintended to be usedwhere smaller implantshave failed.
SurfaceTreatment	SLA	RBM	RBM	SLA	RBM
GammaSterilized	Yes	Yes	Yes	Yes	Yes
Product Code	DZE	DZE, NHA	DZE, NHA	DZE	DZE, NHA

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Image /page/6/Picture/0 description: The image shows the logo for Dentis. The logo features an orange swirl design on the left side. To the right of the swirl is the word "DENTIS" in a bold, sans-serif font.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea

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Image /page/7/Picture/0 description: The image contains the logo for DENTIS. The logo features an orange abstract shape on the left, resembling a flame or a stylized leaf. To the right of the shape, the word "DENTIS" is written in bold, black capital letters. The overall design is simple and professional.

Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

Substantial Equivalence Discussion

The OneQ-SL s-Clean Implant System has a substantially equivalent intended use as the identified predicates. The subject device is similar in fundamental scientific technology to the predicate device in that they all have been designed. manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant Abutments, and they are all constructed of titanium.

The subject and predicate devices are similar in indication for use, material, connection structure, packaging, function, using abutments, performance, design, technology and dimensions. The OneQ-SL s-Clean Implant system is compatible with abutment in s-Clean part of the Dentis Dental Implant System. This subject device is same with SLA surface treatment of OneQ-SL Implant System of the K142313 that have had same material, manufacturing process, packaging, sterilization condition and surface characteristic.

The differences between the subject device and predicate devices are fixture's diameters and similar thread shape.

The subject device platform diameters are Ø3.7, Ø3.9, Ø4.2, Ø4.7, Ø5.2, Ø6.0, Ø7.0 and Ø8.0. The predicate device platform diameters are Ø3.5, Ø3.7, Ø4.1, Ø 4.3, Ø4.8, Ø 5.1, Ø5.5, Ø6.0, Ø6.5, and Ø7.0 (K073486).

The predicate device platform diameters are Ø 3.7. Ø 5.2. Ø 6.0 and Ø 7.0. (K142313).

The subject device's thread is composed of double thread types and predicate device (K150344)'s threads are composed of micro thread and macro thread of buttress thread type. Reference predicate K063216 supports the substantial equivalence of the subject device's wide fixture with a diameter of 8.0mm.

This implant system has been subjected to several performance and product validations prior to release. Nonclinical tests, including biocompatibility have been performed to ensure the device comply with the applicable International and US regulations.

Differences in technological characteristics do not raise different questions compared to the predicate devices.

Non-Clinical Test Data

The subject device was tested to evaluate its substantial equivalence according to the following standards.

Gamma Sterilization Validation Test performed in accordance with ISO11137-1
Shelf life Validation Test performed in accordance with ISO 11607-1, -2, ASTM F1980-07 ●
Biocompatibility tests performed in accordance with ISO 10993-1, ISO 10993-3, ISO 10993-5, ● ISO 10993-6, ISO 10993-10 and ISO 10993-11.

Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the Dental Implant System (K150344) in s-Clean tapered Fixture and the angled abutment in support. Therefore, Submitted fatigue test report can be used as a proof of OneQ-SL c-Clean implant system.

Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The results of the above tests have met the standards, and demonstrated the substantial equivalence with the predicate device.

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Image /page/8/Picture/0 description: The image shows the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a curved check mark with a circle at the top. The graphic is gradient, with the color fading from dark orange to light orange.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.

Summary of clinical testing

No clinical testing was performed for this submission.

Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentis Co., Ltd. Concludes that the OneQ-SL s-Clean Implant System is substantially equivalent to the predicate devices as described herein.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.